SS 29Apr2015

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Meeting Record

When: 10:00 am - 11:00 am, 29Apr2015
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Hanming Tu
Attendance: Mat, Dante, Steve, Peter, Hanming
Excused: Mary, Dirk

  1. Steering committee - Mary/Steve
  2. Review action items
  3. Plan for All-hands meeting
  4. Project Update
  5. Special events
    1. 2015 CSS debriefing - PhUSE Webinar (date is not defined)
    2. PharmaSUG/Scriptathon
    3. PhUSE Annual Conference/Scriptathon (deadline is the end of April)

General discussion

Steering Committee Update - Mary
  • CSS reflection:
    • Sunday night meeting may be revised a little
    • Re-position our projects and the committee is OK with the update
    • Asked office to update our listbox but the office wants us to update it.
    • Caution on Referring the scripts to FDA; Do we need to provide more details such as JumpStart scripts?
    • Steve: Working on communication and figure out the deliverable and support in the future
    • Chris D. has accessed the github to create folder structure for deliverable
    • SEND data
Here is what I have done so far
  1. Transferred script repository to phuse-org:
  2. Updated the current project section:
  3. Scanned the sign-up sheet and put it into a pdf file – attached in this invitation
Here is what each of project lead needs to do
  1. Get acquainted: Read the email from Chris and get familiar with the tools that he mentioned. Since we did not create any new project – we just renamed our projects and adjusted our focuses, we do not need to go through “New project request”.
  2. Review the updated projects: I just updated the “Current Projects” section ( Please review and let me know if you find any error or have any suggested change. (Dirk, I did not make the error with your project name and I am not a TLA fanatics. I think the education is important and the best project to include it is yours. So your project abbreviation is CPE. I am maybe a little TLA crazy. )
  3. Polish your project page: Update your project page to reflected the update co-lead name and related information.
  4. Build your team: I attached the signup sheet. Please contact and add the people who are interested in joining your project to your project page.
  5. Craft a plan: Define one or two goals that you would like to achieve for the next PhUSE year (March 2015 ~ March 2016) and have a plan or a listed tasks to be accomplished within the year.
  6. Schedule your recurring team meetings: please reach out to your team members to find out the best time for most of people to have your team meeting.
Project Updates
  • The P01 - SDA project started looking into the AE and MedDRA scripts from FDA
  • The P02 - RCD project updated its project page and started planning for project meeting - Dante/Peter
    • Migrated to github - it is the startpoint
    • Test data from the Github
    • Create a agenda for the project calls - produce minutes
    • First meeting is scheduled in a week 8~10 people accepted invitation
    • Peter - Dante had done some uplifting work during CSS meeting - we simplify it. We will publish it and ask for some feedback
    • Dante: Had two meetings and updated the project page
    • Need to do a feasibility review and define focused tasks
    • Revised qualification process for simple workflow and start signing tasks and move targeted output through these activities
    • Peter introduced backlog management tool -
    • We have about 12 scripts for CT and have close to 10 people on the call; 15 templates for the output of CT package
    • Collect a list of topics - get github setup - folder structure and access control.
  • The P03 - RGI project started working on the standard scripts in Github; added a readme file
  • The P07 - CPE project updated the project page; more volunteers are joined the project
  • The P08 - ADW project updated listbox and scheduled first meeting
    • Move to outlier whitepaper
    • Found a medical writer
  • Outreach Updates
    • Steve/Mat: Change control board - Norman Stockbridge/Mat - open tool box; meeting in the end of June
    • CDISC Interchg in Boston, PhUSE was mentioned; Lot of interests in trials, there is potential need for CDISC in tropical disease trials; emergence data collection standards. TA standards based on PDUFA; Vaccine trials.

Follow up

Action Items
  • Plan a All-hands meeting for the working after March conference
  • FDA plan for releasing the rest of scripts - Steve/Mat
    • meeting every month and will bring it up again
  • Update communication plan to include new deadlines for year 2015 - Dirk [in progress]
  • Update listbox sub-group list:
    • main-list - Mary
    • P02-03 list - Chris
    • white-papers list - Mary
  • Gather finalized whitepapers in word format for publishing to phusewiki and - Mary
  • All-hands meeting will be 6/3 --> 6/23 and Hanming will send out a placeholder for the meeting to co-leads
  • Add project coleads to the - Dante/Peter

Next Meeting

Time: 10:00 am - 11:00 am (Wednesday)
We will conduct this meeting once per month.

Agenda for next meeting: Next meeting: TBD

Last revision by Jmbodart,10/13/2015